Executive Director, Clinical Data Management Greater San Francisco, CA Area

The Company is seeking a Senior Director or Executive Director to lead Clinical Data Management across its clinical studies. The role will set the function’s strategy and operating model, establish data governance, and prepare the organization to scale from early-stage studies to pivotal trials and regulatory submissions. Responsibilities include overseeing study data delivery, database changes and locks, external data flows, data quality, and inspection readiness. The leader will also manage CROs and other vendors, budgets, and resources, while partnering across clinical, statistical, safety, regulatory, and related functions and developing the CDM team. Candidates must have a bachelor’s or master’s degree in a science- or health-related field, or equivalent education and experience, and at least 12 years of clinical data management experience (15 years for Executive Director), including five or more years leading a CDM function or major program. Required experience includes leading data management through a pivotal-study database lock and contributing to a marketing application, along with strong knowledge of EDC systems, data standards, GCP, regulatory guidance, coding, and quality practices. Candidates should also bring sponsor-side CRO and vendor oversight, operating-model development, and people-management experience. Experience in immunology, complex biologics, global studies, or preparing for an initial regulatory submission is preferred.

Hiring Company

Nkarta, Inc.